Pramipexole Teva 0.18 mg tablets

Pramipexole Teva is a dopamine agonistand works by stimulating dopamine receptors in the brain. In Parkinson?s disease levels of dopamine in the brain are low and Pramipexole Teva works by mimicking the action of dopamine.

Pramipexole Teva is used in the treatment of Parkinson?s disease alone or in combination with another medicine called levodopa .

Do NOT take Pramipexole Teva

• If you are allergic (hypersensitive) to pramipexole or any of the other ingredients of this medicine.

Take special care with Pramipexole Teva

Tell your doctor before you start to take this medicine if:

• You have kidney problems (you may need a lower dose of Pramipexole Teva)
• You have hallucinations (seeing, hearing or feeling things that are not there). Most hallucinations are visual.
• You have dyskinesia (e.g. abnormal, uncontrolled movements of the limbs) If you have advanced Parkinson?s disease and are also taking levodopa, you might develop dyskinesia during the uptitration of Pramipexole Teva.
• You have a mental illness such as schizophrenia or depression
• You have heart problems (your doctor may decide to do check-ups more often during treatment to make sure that your blood pressure does not fall too low).

You should tell your doctor if you experience sleepiness or episodes of suddenly falling asleep. You should tell your doctor if you (or your carer) notice any changes in your behaviour. Such changes may be an abnormal desire to gamble, compulsive shopping, increased libido (sex drive) or excessive and uncontrollable overeating. Your doctor may lower the dose of Pramipexole Teva or stop your treatment.

You should tell your doctor if you notice any changes to your eyesight. Your eyes may need regular check-ups.

Taking other medicines

The effects of Pramipexole Teva may be altered or side effects may occur if you are also taking other medicines. Talk to your doctor if you are taking any of the following:

• Medicines which affect kidney function or are excreted by the kidneys, e.g. cimetidine (used to treat indigestion and other stomach problems) and amantidine (used to manage Parkinson?s disease)
• Levodopa (used to manage Parkinson?s disease)
• Medicines used to treat mental illnesses such as schizophrenia or depression
• Other medicines which can cause drowsiness since the drowsiness may become worse in the combination with Pramipexole Teva.
• zidovudine (which can be used to treat the acquired immune deficiency syndrome (AIDS), a disease of the human immune system);
• cisplatin (to treat various types of cancers);
• quinine (which can be used for the prevention of painful night-time leg cramps and for the treatment of a type of malaria known as falciparum malaria (malignant malaria));
• procainamide (to treat irregular heart beat).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Pramipexole Teva with food and drink

Pramipexole Teva can be taken with or without food and should be swallowed with a sufficient amount of water. If you experience drowsiness this can be made worse if you drink alcohol.

Pregnancy and breast-feeding

If you are pregnant or planning to become pregnant Pramipexole Teva should only be used if your doctor considers it to be absolutely necessary. The effects of Pramipexole Teva on the unborn child are not known.

You should not take Pramipexole Teva if you are breast-feeding. Pramipexole Teva may stop milk production. Also, it can pass into the breast milk and can reach your baby and the effects of this are not known.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Pramipexole Teva may cause hallucinations and sleepiness, and you may fall asleep suddenly without any warning. If you experience these effects, do not drive, operate machinery or perform any other dangerous task that requires your full attention. You should also tell your doctor as he/she may need to lower your dose of Pramipexole Teva or stop your treatment altogether.

Always take Pramipexole Teva exactly as your doctor has told you. You should check with your doctor if you are not sure.

Pramipexole Teva should be taken three times a day. The tablets can be taken with or without food and should be swallowed with a glass of water. You can break the tablets to make it easier to swallow them if necessary.

The treatment with Pramipexole Teva normally starts with a low dose which is gradually increased every 5 to 7 days until the right dose for your needs is reached (the ?maintenance dose?).

The normal starting dose is one Pramipexole Teva 0.088 mg tablet three times a day (a daily dose of 0.264 mg of pramipexole).

The usual maintenance dose is 1.1 mg per day. However, your dose may have to be increased even further. If necessary, your doctor may increase your tablet dose up to a maximum of 3.3 mg of pramipexole a day. A lower maintenance dose of three Pramipexole Teva 0.088 mg tablets a day is also possible.

Your doctor may decide to change your maintenance dose depending on your response to the treatment and any side effects that you experience.

If your doctor decides to stop your treatment, the dose will be reduced slowly until treatment is stopped.

Patients with kidney disease

If you have moderate or severe kidney disease, your doctor will prescribe a lower dose. In this case, you will have to take the tablets only once or twice a day. If you have moderate kidney disease, the usual starting dose is 1 tablet Pramipexole Teva 0.088 mg twice a day. In severe kidney disease, the usual starting dose is just 1 tablet Pramipexole Teva 0.088 mg a day.

If you take more Pramipexole Teva than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause nausea, vomiting, abnormal muscular movements, hallucinations, agitation and low blood pressure (which might cause light-headedness and dizziness). Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed. Medical treatment may be necessary.

If you forget to take Pramipexole Teva

If you miss a tablet then you should take it as soon as you remember. However, if it is nearly time for your next tablet then you should skip the dose you missed and take your next tablet as normal. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Pramipexole Teva

You should not stop taking your medicine or reduce your dose without discussing it with your doctor first. It is dangerous to stop taking this medicine suddenly. If you need to stop your treatment your doctor will reduce your dose slowly.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Pramipexole Teva can cause side effects, although not everybody gets them. Evaluation of the side effects is based on the following frequencies:

Very common affects more than 1 user in 10 Common affects 1 to 10 users in 100 Uncommon affects 1 to 10 users in 1,000 Rare affects 1 to 10 users in 10,000 Very Rare affects less than 1 user in 10,000 Not known frequency cannot be estimated from the available data

Very common:

• Dyskinesia (e.g. abnormal, uncontrolled movement of the limbs)
• Sleepiness
• Dizziness
• Nausea (sickness)

Common:

• Urge to behave in an unusual way
• Hallucinations (seeing, hearing or feeling things that are not there)
• Confusion
• Tiredness (fatigue)
• Sleeplessness (insomnia)
• Excess fluid, usually in the legs (peripheral oedema)
• Headache
• Hypotension (Low blood pressure)
• Abnormal dreams
• Constipation
• Visual impairment
• Vomiting (being sick)
• Weight loss including decreased appetite

Uncommon:

• Paranoia (e.g. excessive fear for one?s own well-being)
• Delusion
• Excessive daytime sleepiness and falling asleep suddenly
• Amnesia (memory disturbance)
• Hyperkinesia (increased movements and inability to keep still)
• Weight increase
• Increased sexual desire drive (e.g. increased libido)
• Allergic reactions (e.g. rash, itching, hypersensitivity)
• Fainting
• Pathological gambling, especially when taking high doses of Pramipexole Teva
• Hypersexuality
• Increased eating (binge eating, hyperphagia)
• Restlessness
• Compulsive shopping
• Dyspnoea (difficulties to breathe)
• hiccups
• Pneumonia (infection of the lungs)

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Keep out of the reach and sight of children.
Do not use Pramipexole Teva after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month.
Do not store above 25 ºC.
Store in the original package in order to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Pramipexole Teva contains

The active substance is pramipexole.

Pramipexole Teva 0.088 mg tablets: one tablet contains 0.088 mg pramipexole equivalent to 0.125 mg pramipexole dihydrochloride monohydrate
Pramipexole Teva 0.18 mg tablets: one tablet contains 0.18 mg pramipexole equivalent to 0.25 mg of pramipexole dihydrochloride monohydrate
Pramipexole Teva 0.35 mg tablets: one tablet contains 0.35 mg pramipexole equivalent to 0.5 mg pramipexole dihydrochloride monohydrate
Pramipexole Teva 0.7 mg tablets: one tablet contains 0.7 mg pramipexole equivalent to 1.0 mg pramipexole dihydrochloride monohydrate

The other ingredients are mannitol, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, sodium stearyl fumarate, colloidal silicon dioxide .

What Pramipexole Teva looks like and contents of the pack

• Pramipexole Teva 0.088 mg tablets are white, round tablets, embossed with "93" on one side and "P1" on the other side.
• Pramipexole Teva 0.18 mg tablets are white round, scored tablets embossed with "P2" over "P2" on the scored side and "93" on the other side. The tablet can be divided into equal halves.
• Pramipexole Teva 0.35 mg tablets are white, oval, biconvex tablets, engraved with 9 vertical scoreline 3 on the scored side, and 8023 on the other side. The tablet can be divided into equal halves.
• Pramipexole Teva 0.7 mg tablets are white, round, scored tablets embossed with "8024" over "8024" on the scored side and "93" on the other side. The tablet can be divided into equal halves.
• Pramipexole Teva tablets are available in blister packs of 30, 30 x 1, 50 x 1, 100 x 1 and 100 tablets and bottles containing 90 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma B.V.
Computerweg 10, 3542 DR Utrecht
The Netherlands

Manufacturer:
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13,

4042 Debrecen,
Hungary

Or:

TEVA Pharmaceutical Works Private Limited Company

H-2100 Gödöll-,

Táncsics Mihály út 82

Hungary

Or:

TEVA UK Ltd

Brampton Road,

Hampden Park,Eastbourne,East Sussex,
BN22 9AG

United Kingdom

Or:

Pharmachemie B.V.

Swensweg 5,
Postbus 552,

2003 RN Haarlem

The Netherlands

Or:

TEVA Santé Sa,

Rue Bellocier, 89107,

Sens,

France

Or

Teva Czech Industries s.r.o

Ostravska 29, c.p. 305

747 70 Opava-Komarov

Czech Republic

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

LuxembourgLuxemburg Teva Pharma Belgium N.V.S.A.AG. Tél 32 3 820 73 73 Magyarország Teva Magyarország Zrt Tel. 36 1 288 64 00 BelgiëBelgiqueBelgien Teva Pharma Belgium N.V.S.A. TelTél 32 3 820 73 73 Te 359 2 489 95 82 eská republika Teva Pharmaceuticals CR, s.r.o. Tel 420 606 763 892 Malta Teva .. el 30 210 72 79 099

Danmark Teva Denmark A.S. Tlf 45 44 98 55 11 Nederland Teva Nederland B.V. Tel 31 0 800 0228400 Norge Teva Sweden AB Tlf 46 42 12 11 00 Österreich Teva GmbH Tel 49 351 834 0 Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel. 48 22 345 93 00 Portugal Teva Pharma - Produtos Farmacêuticos Lda Tel 351 214 235 910 România Teva Pharmaceuticals S.R.L Tel 4021 230 65 24 Slovenija Teva UK Limited Tel 44 1323 501 111 Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Tel 421 2 5726 7911 SuomiFinland Teva Sweden AB PuhTel 46 42 12 11 00 Sverige Teva Sweden AB Tel 46 42 12 11 00 United Kingdom Teva UK Limited Tel 44 1323 501 111 Deutschland Teva GmbH Tel 49 351 834 0 Eesti Teva Eesti esindus UAB Sicor Biotech Eesti filiaal Tel 372 611 2409 Teva .. 30 210 72 79 099 España Teva Pharma, S.L.U Tél 34 91 387 32 80 France Teva Santé Tél 33 1 55 91 7800 Ireland Teva Pharmaceuticals Ireland Tel 353 042 9395 892 Ísland Teva UK Limited Sími 44 1323 501 111. Italia Teva Italia S.r.l. Tel 39 0289179805 Teva .. 30 210 72 79 099 Latvija UAB Sicor Biotech Latvian Affiliate Tel 371 67 784 980 Lietuva UAB Sicor Biotech Tel 370 5 266 02 03

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